Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides

NCT00672633 | Terminated Phase 2 Results DMC

• 1 other identifier: 08010028
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a randomized clinical trial to evaluate the efficacy of Lovaza (formerly known as Omacor) in reducing triglyceride levels in youth ages 10-19 years old whose baseline triglycerides range from 150 mg/dl to 1000 mg/dl. Seventy subjects will be recruited at baseline and randomized to the treatment condition, Lovaza 4 grams/day for 6 months or the control condition, a corn oil placebo, 4 tablets a day for 6 months. Participants in both the treatment and control groups will receive the standard of care, which is dietary advice to follow a low, refined carbohydrate and low saturated fat diet that emphasizes increasing intake of fruits and vegetables and eating 2 servings per week of fishes rich in omega-3 fatty acids, consistent with the American Heart Association recommendations. The primary outcome will be change in fasting triglycerides from baseline to 3 months. The investigators hypothesize that patients who receive LOVAZA will have significantly greater reductions in plasma triglyceride levels when compared to patients on placebo at 3 months.

Conditions

Hypertriglyceridemia

Keywords

Omega 3 Fatty Acids; Triglycerides; Lovaza; Trial

Outcome Measures

Primary Outcomes (1)

• Fasting Triglycerides

  Fasting Triglycerides

  3 months

Secondary Outcomes (2)

• LDL Cholesterol

  3 months

• HDL Cholesterol

  3 months

Study Arms (2)

A , Experimental

EXPERIMENTAL

Lovaza, 4 grams/day orally for 6 months

Drug: Lovaza

Corn Oil Pill

PLACEBO COMPARATOR

Corn Oil Pill, 4 pills/day orally for 6 months

Drug: Placebo

Interventions

Lovaza DRUG

Lovaza , 4 grams/day orally for 6 months

A , Experimental

Placebo DRUG

Corn Oil Pill, 4 pills/day orally for 6 months

Also known as: Corn Oil Pill

Corn Oil Pill

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 10-19 years old
• Fasting Triglyceride levels of 150-1000 mg/dl at the screening and baseline visit
• Ability to swallow pills
• Informed consent from a parent or legal guardian of minors or adult subject
• Written assent from the adolescent to participate in the study
• English or Spanish speaking

You may not qualify if:

• Food Allergy to Fish or any components of the pills which includes alpha tocopherol, partially hydrogenated vegetable oils including soybean oils and gelatin and glycerol or corn oil, and iron oxide or iron oxide containing food color additives.
• Pregnancy or positive urine pregnancy test for those females who have begun menstruating
• Breast feeding
• Alcohol Use: Patient is unable to abstain from alcohol use during the study. This will be assessed by asking the following questions: "During the past 30 days, on how many days did you have at least one drink of alcohol?"; "During the past 30 days, on how many days did you have 5 or more drinks of alcohol in a row, that is, within a couple of hours?"; "This study requires that you abstain from alcohol use during the course of the study. Do you think you can do this?"
• Known Bleeding Disorder or Coagulopathy or treatment with anticoagulant medications or low platelet counts, abnormal PT, or PTT.
• Significant cognitive or psychosocial disorder or medical illness that would limit participation in the trial.
• Type 1 or 2 Diabetes or fasting glucose that is \>=126 mg/dl
• Liver disease or an ALT greater than 2 times upper limit of normal
• Treatment with medications that affect triglyceride levels, including oral hypoglycemic agents or insulin.
• Be currently taking the same oral contraceptive pills for less than the past three months or intend to change or discontinue prescription oral contraceptive pills used in the next seven months
• Be currently taking any over-the-counter supplements that affect triglycerides or lipid metabolism including over the counter fish oil supplements.
• Treatment for or diagnosis of a thyroid disorder or an elevated TSH level at baseline

Sponsors & Collaborators

• Boston Children's Hospital: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Omacor; Corn Oil

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. Stavroula Osganian, Principal Investigator
• Organization: Boston Children's Hospital

stavroula.osganian@childrens.harvard.edu

8572184728

Study Officials

• Stavroula K Osganian, MD, ScD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Sara DeFerranti, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Scientist

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 6, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: May 29, 2013
• Results First Posted: May 29, 2013

Record last verified: 2013-05

Locations

US (1)